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NOT YET RECRUITING
NCT07691515
PHASE3

A Phase III Trial of Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma. Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.

Official title: Transcatheter Arterial Chemoembolization in Combination With Tislelizumab Plus Lenvatinib Versus Systemic Cisplatin Plus Gemcitabine in Combination With Tislelizumab for Unresectable Intrahepatic Cholangiocarcinoma: A Phase III, Multicenter, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-07

Completion Date

2030-07

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

DRUG

Gemcitabine

Gemcitabine 1000 mg/m² intravenously on Days 1 and 8 of each 21-day cycle, up to 8 cycles.

DRUG

Cisplatin

Cisplatin 25 mg/m² intravenously on Day 1 and Day 8 of each 21-day cycle, up to 8 cycles.

DRUG

Tislelizumab

Tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle, followed by maintenance tislelizumab every 3 weeks.

DRUG

Lenvatinib

Oral lenvatinib once daily, 12 mg for participants with body weight ≥60 kg or 8 mg for participants with body weight \<60 kg, with dose modification according to toxicity.

PROCEDURE

Transcatheter Arterial Chemoembolization

Conventional TACE or drug-eluting bead TACE are allowed. TACE may be repeated based on imaging assessment every 6 weeks ±7 days and investigator judgment.

PROCEDURE

Hepatic Arterial Infusion Chemotherapy

Optional hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to protocol-defined dose ranges.

Locations (18)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

The Affiliated Panyu Central Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Ganzhou Hospital-Nanfang Hospital, Southern Medical University

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Affiliated Hospital of QingDao University

Qingdao, Shandong, China

West China School of Medicine/West China Hospital, Sichuan University (WCSM/WCH, SCU)

Chengdu, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

NingBo No.2 Hospital

Ningbo, Zhejiang, China

NingBo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China